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The MHICC is now Seriant !
The Montreal Health Innovations Coordinating Center (MHICC) is now Seriant.
Our new name reflects a bold step forward— expanding beyond cardiology and embracing innovations in clinical trials with a global reach.
While our identity has evolved, our commitment to operational excellence, client satisfaction, and quality remains the same.
Medical and Safety Oversight
Ensuring the safety of study participants and the integrity of clinical data is critical.
Our Medical Monitoring and Safety experts are dedicated to identifying and addressing potential safety risks throughout the entire study lifecycle from startup to study closeout.
By working closely with all stakeholders, our end-to-end Medical and Safety Monitoring services are available as an integral component of a full-service contract or as an à la carte option tailored to your specific needs. We provide proactive oversight that helps mitigate risks and ensures that safety is never compromised.
To ensure patient protection, regulatory compliance, and high-quality data throughout the clinical trial lifecycle, our team is dedicated to data surveillance.
- Safety Data Review through ongoing analysis of adverse events (AEs), serious adverse events (SAEs), and signal detection for early intervention
- Medical Monitoring support to internal and external teams
- Medical Monitoring & Risk Management through data surveillance, protocol adherence, and proactive risk mitigation strategies
- Integrated Safety & Medical Data through seamless coordination between medical, biostatistics, and data management to ensure comprehensive safety analysis
We provide end-to-end management of safety committees to ensure rigorous oversight, safety and data integrity in clinical trials:
- Establish and manage safety committees, i.e. Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC)
- Establish and manage Endpoint Adjudication Committee (EAC) or Clinical Endpoint/Events Committee (CEC)
- End-to-end management of the event adjudication process
We provide expert medical guidance through seamless collaboration with sites, sponsors and other stakeholders to ensure compliance, patient safety, and optimal study execution.
- Providing site staff, vendors, and stakeholders with specialized support on protocol requirements, eligibility criteria, and medically related inquiries to ensure compliance and accuracy
- Offering real-time guidance on safety signals, protocol deviations, and risk mitigation strategies to safeguard patient well-being and study integrity
- Transparent Communication & Decision Support through reporting and collaboration between investigators, regulators, and sponsors to drive informed decisions
- Dedicated Support for Sites & Vendors— Ensuring seamless coordination and expert consultation to optimize study execution, accelerate issue resolution, and enhance overall trial performance
Interested in this service?
Let’s work together!
